510(k) · Cleared
ClearedAthelas One
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Athelas, Inc. · GKZ Counter, Differential Cell
Cleared on Nov 5, 2018 as substantially equivalent to K071967 (Sysmex America, Inc., 2007) after a 173-day review. Its family tree reaches back 2 generations to 2004. 2 later devices descend from it.
- Decided
- Nov 5, 2018
- Review
- 173 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040073 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK040073 Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100…Sysmex America, Inc. · 2004
- 1 generation backK071967 Sysmex XE-5000Sysmex America, Inc. · 2007 · Recalled
- This deviceK181288 Athelas OneAthelas, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK200828 Athelas HomeAthelas, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK243348 Athelas HomeAthelas, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040073 | Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L) | Sysmex America, Inc. | 2004 | — |
| −1 | K071967 | Sysmex XE-5000 | Sysmex America, Inc. | 2007 | 1 |
| 0 (this device) | K181288 | Athelas One | Athelas, Inc. | 2018 | — |
| +1 | K200828 | Athelas Home | Athelas, Inc. | 2022 | — |
| +1 | K243348 | Athelas Home | Athelas, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071967 | Sysmex XE-5000Summary page 4…e settings. The Athelas One is only indicated for use in adult populations (aged 21 and older). Substantial Equivalence: Sysmex XE-5000, Automated Haematology Analyzer (K071967) Comparison with predicate: Similarities Item D… | 2007 |
| † | K112605 | Sysmex XN-Series | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K200828 (Athelas, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K071967.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
Athelas One is indicated for use for quantitative determination of white blood cells (WBC) and Neutrophil percentages (NEUT%) in capillary or K2EDTA venous whole blood. The Athelas One system is for In Vitro Diagnostic use only. The Athelas One is only to be used with Athelas One Test Strips. The Athelas One is indicated for use in clinical laboratories and for point of care settings. The Athelas One is only indicated for use in adult populations (aged 21 and older).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181288: Athelas One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181288
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026